An international study including researchers from University of Texas Medicine San Antonio and Texas Liver Institute announced significant success in the treatment of hepatitis C infection in patients with liver cirrhosis. More than 90% of patients treated for 12 weeks with an investigational oral therapy regimen were cured of their hepatitis C infection and tolerated treatment. To put this in perspective, traditional hepatitis C cure rates in patients with liver cirrhosis are lower than 50%, and many patients do not tolerate the treatments.
“These are out-of-the-ballpark response rates, not on the same planet as interferon,” said Fred Poordad, MD, in a press release from UTHSC. Interferon is a major agent used in the battle against hepatitis C treatment, but patients who receive this treatment commonly relapse and experience multiple side effects. According to Dr. Poordad, “The reason this study is so profound is because interferon is not tolerated nor is it safe in many people with cirrhosis. Many of the patients with cirrhosis in this study were not even eligible to be treated with interferon.” The regimen under review is interferon-free and uses several agents: ABT-450/ritonavir (protease inhibitor), ombitasvir (NS5A inhibitor), dasabuvir (nonnucleoside polymerase inhibitor), and ribavirin (guanosine analog). Twelve weeks of taking a combination of pills was enough to lower infection in 91.8% of patients to undetectable levels within twelve weeks of taking the last dose; 24 weeks of treatment increased the cure rate to 95.9% within twelve weeks of taking the last dose.
Retired San Antonio anesthesiologist Sergio Buentello, MD, perfectly exemplifies the impact of this treatment. Dr. Buentello was diagnosed with hepatitis C infection eleven years ago and received treatment eight years ago, but he was disappointed with the results. “My viral count came down, but never to zero,” he said. Then, when he was approached by Eric Lawitz, MD, of the Texas Liver Institute, about the possibility of receiving investigational treatment, he hesitantly accepted. Now, he says, “I feel very lucky to be living in this time, because I was almost resigned to the idea that I could never be cured.”
Dr. Buentello was accompanied by 379 other patients at 78 international sites in the study published in The New England Journal of Medicine. Patient blood samples will be cataloged for three years past therapy to detect late relapses. So far, none has occurred, prompting Dr. Poordad to state, “Patients with advanced liver disease can now be cured of their hepatitis with a very well-tolerated and short regimen.”
The regimen, which was supported by the biopharmaceutical company AbbVie, is slated to be on the market at the end of 2014 or early in 2015. With hope, the regimen will attenuate hepatitis C infection, which is the primary driver of liver cirrhosis, liver transplants, and liver cancer in the United States.